Business Club December 23 The global regulatory oversight of traditional medicines is pressing harder and harder. At present, western countries such as the European Union, Australia, and Canada have already implemented legislative management of Chinese medicine or traditional medicine. Following the entry into force of the Chinese Medicine Ordinance of Hong Kong on December 3, after the unregistered Chinese patent medicines are forbidden to be sold in Hong Kong, the 7-year transitional period of the European Union's "Regulations on the Registration of Traditional Plant Drugs" that has attracted the attention of the industry will also be held next year. Expires on March 31.
"Beginning next April, my Chinese medicine exports to Europe will inevitably be affected to a certain extent. This is inevitable." Secretary-General Cui Bin of the China Import & Export Business Association of Pharmaceuticals and Health Products told the reporter of the "Medicine Economics" that in the face of international The most complicating factor in the foreign trade environment is that the supervision and control of drugs has been greatly strengthened in various countries. This will also affect my foreign export transactions for a long period of time. Cui Bin revealed that the Chamber of Commerce is working with the State Food and Drug Administration to discuss the registration of traditional botanicals in the EU. Guidelines for the quality control of Chinese medicine exports will also be available early next year.
The "Directive" mainly focuses on proprietary Chinese medicines
According to the “Regulations on Traditional Plant Drug Registration Procedures†promulgated by the European Union on March 31, 2004, all botanicals sold on the EU market must be registered under this new regulation and must be approved for marketing before they can continue to be sold. At the same time, the directive stipulates a seven-year transitional period, allowing herbal products sold in European Union countries to be sold on March 31, 2011. At present, most of the Chinese herbal medicines in the EU market are circulated in the form of food, health products, botanical raw materials or agricultural and sideline native products. With the end of the seven-year transitional period, the breakthrough in the official registration of Chinese medicines in the EU remains unresolved.
The reporter found that the "Regulations on the Registration of Traditional Plant Drugs", as the first European legislation on traditional herbal medicines, required the registration of a list of traditional herbal medicines that met the four types of conditions: First, non-prescription drugs; second, oral, external or inhalation. The preparations and injections cannot be registered; the third is the traditional service life requirement: the product must have a service life of more than 30 years, including at least 15 years of use in EU countries; fourth, the product raw materials meet the requirements. The directive requires that only products derived from botanical drugs be listed on the market. If botanicals contain vitamins or minerals, and vitamins or minerals only play a supporting role, they can also be listed on the market. Animal medicines cannot be registered for listing under this directive.
“Currently, Chinese herbal medicines and single-taste granules can still be sold as food and food supplements.†Cui Bin pointed out that some classical Chinese medicines that have been recorded in the Chinese Pharmacopoeia for more than 15 years, contain no toxic medicinal materials and are still widely used, Liuwei Dihuang Pills, Wuji Baifeng Pills and so on have entered the EU market as early as 1995. At present, the "Directive of Traditional Chinese Herbal Medicine Registration Procedures" is more targeted for the registration and listing of proprietary Chinese medicines, but there are differences in the specific methods and measures of EU member states, of which the Netherlands is relatively relaxed.
Medical Insurance Association statistics show that the first three quarters of this year, China's exports of Chinese medicine products reached 135.062 million US dollars, an increase of 20.46%. Among them, the export volume of Chinese herbal extracts amounted to US$583.375 million, a year-on-year increase of 14.35%; the export value of Chinese herbal medicines and decoction pieces was US$50,898,130, an increase of 25.93% year-on-year; the export value of health products was US$116.694 million, an increase of 33.49% year-on-year; the exports of Chinese patent medicines were 14.61518 million. The United States dollar, an increase of 18.55%.
The EU and China Hong Kong have always been the two pillar markets for Chinese medicine exports. Although Chinese patent medicines account for a relatively small proportion in the export structure of Chinese medicines, the registration of Chinese patent medicines in the EU is a crucial step in the internationalization of Chinese medicine and cannot be ignored.
The reporter learned that at present, some companies are actively working hard to secure the successful registration of products in the EU before the end of the transitional period. It is reported that Chengdu Dioxinxuekang Capsule in Chengdu, Sichuan Province has passed the review of the Dutch drug administration department. The Dioxinxuekang capsule production line has also passed the EU GMP certification and is expected to become the first therapeutic Chinese proprietary drug product to enter the international market; Guangyao Group Qixing Pharmaceutical Acquired the project of simple registration of traditional British herbal products and GMP certification of EU (UK) Drugs; Lanzhou Foci "Lanshan" brand concentrated Angelica Pill has also been approved and formally accepted by Swedish National Drug Administration, and pre-assessment has also been passed. .
In fact, although the European Union has issued the "Regulations on Traditional Plant Drug Registration Procedures", it does not require that all Chinese medicine products will be managed by drugs in the future. “Actually, many Chinese medicine products can also be legally sold in the European Union according to food, food supplements or cosmetics.†Wang Haitao, a manager of a franchised Chinese medicine foreign trade company, told reporters that the EU and Hong Kong have always been the company’s major export markets, compared to Hong Kong’s. The threshold is lower than that of the European Union. At present, there is not yet one product registered in the EU, because companies are generally unable to provide proof of the 15 years of sales in the EU as stipulated in the “Directive of Traditional Plant Drug Registration Proceduresâ€. However, at the same time, he disclosed that at present, the company is actively applying for Chinese-style Chinese herbal medicines, and more than 90 varieties will be declared and completed before the end of this year. They are all new varieties exported to the EU market.
Drug research data needs to be improved
Yu Zhibin, a member of the Chinese Medicinal Insurance Association, told this reporter that the current stable and reliable compound preparations for quality control standards are still registerable in many EU countries. It is reported that Britain, Finland and Germany have already approved the registration of a compound preparation containing 2 to 13 components. Of the traditional Chinese herbal medicines that are registered, at least nine components are also traditional Chinese medicines.
Yu Zhibin introduced that Chinese medicines are registered on the European Union market. Currently, there are mainly two ways of registration and listing. Among them, Chinese medicines that have never been listed in the European Union, or those that have already been marketed in the European Union but are required to apply for new indications, are all eligible for registration.
It is reported that for the registration of traditional Chinese medicines that have never been listed in the European Union, the EU has requested new clinical research data and clinical trial data. The relevant drug administration agencies of the European Union must conduct safety, effectiveness, and quality controllability. Strict review. For the Chinese medicines that require new indications, the EU requires that they must be complete varieties of Chinese medicines. If the applicant can provide scientific literature on safety and efficacy, the EU will not have to re-examine clinical data and clinical trials.
Werner Kanos, the official of the German Federal Drug and Medical Device Authority, stated that “requiring 15 years of use in the EU†has become an obstacle that everyone is concerned about. In fact, it can be provided by the Chinese community, and exceptions can be released. However, he did not give details on the specific release criteria.
It is understood that for registration on the market, the EU allows eligible traditional herbal medicines to simplify filing requirements. At the same time, for the products listed on the market, if there is a list of EU herbal monographs or EU raw materials, the traditional use of evidence and expert reports, literature or new research materials can be exempted. It is reported that the European Union's "Regulations on Traditional Plant Drug Registration Procedures" stipulates that traditional herbal medicines "have at least 30 years of medicinal history before the filing date, including at least 15 years of use history in the EU." Proof of the above-mentioned history of traditional application is based on publicly published literature, expert reports and customs records of import and export records also belong to the certification document.
In addition, the reporter also learned that the Registration Department of the State Food and Drug Administration is currently stepping up its research on the guiding principles of research techniques for natural medicines. The introduction of this policy will provide clinical research data and clinical trials on the future of Chinese medicine exports to effectively meet international demand. The international convergence of other technical indicators is of great benefit.
"Beginning next April, my Chinese medicine exports to Europe will inevitably be affected to a certain extent. This is inevitable." Secretary-General Cui Bin of the China Import & Export Business Association of Pharmaceuticals and Health Products told the reporter of the "Medicine Economics" that in the face of international The most complicating factor in the foreign trade environment is that the supervision and control of drugs has been greatly strengthened in various countries. This will also affect my foreign export transactions for a long period of time. Cui Bin revealed that the Chamber of Commerce is working with the State Food and Drug Administration to discuss the registration of traditional botanicals in the EU. Guidelines for the quality control of Chinese medicine exports will also be available early next year.
The "Directive" mainly focuses on proprietary Chinese medicines
According to the “Regulations on Traditional Plant Drug Registration Procedures†promulgated by the European Union on March 31, 2004, all botanicals sold on the EU market must be registered under this new regulation and must be approved for marketing before they can continue to be sold. At the same time, the directive stipulates a seven-year transitional period, allowing herbal products sold in European Union countries to be sold on March 31, 2011. At present, most of the Chinese herbal medicines in the EU market are circulated in the form of food, health products, botanical raw materials or agricultural and sideline native products. With the end of the seven-year transitional period, the breakthrough in the official registration of Chinese medicines in the EU remains unresolved.
The reporter found that the "Regulations on the Registration of Traditional Plant Drugs", as the first European legislation on traditional herbal medicines, required the registration of a list of traditional herbal medicines that met the four types of conditions: First, non-prescription drugs; second, oral, external or inhalation. The preparations and injections cannot be registered; the third is the traditional service life requirement: the product must have a service life of more than 30 years, including at least 15 years of use in EU countries; fourth, the product raw materials meet the requirements. The directive requires that only products derived from botanical drugs be listed on the market. If botanicals contain vitamins or minerals, and vitamins or minerals only play a supporting role, they can also be listed on the market. Animal medicines cannot be registered for listing under this directive.
“Currently, Chinese herbal medicines and single-taste granules can still be sold as food and food supplements.†Cui Bin pointed out that some classical Chinese medicines that have been recorded in the Chinese Pharmacopoeia for more than 15 years, contain no toxic medicinal materials and are still widely used, Liuwei Dihuang Pills, Wuji Baifeng Pills and so on have entered the EU market as early as 1995. At present, the "Directive of Traditional Chinese Herbal Medicine Registration Procedures" is more targeted for the registration and listing of proprietary Chinese medicines, but there are differences in the specific methods and measures of EU member states, of which the Netherlands is relatively relaxed.
Medical Insurance Association statistics show that the first three quarters of this year, China's exports of Chinese medicine products reached 135.062 million US dollars, an increase of 20.46%. Among them, the export volume of Chinese herbal extracts amounted to US$583.375 million, a year-on-year increase of 14.35%; the export value of Chinese herbal medicines and decoction pieces was US$50,898,130, an increase of 25.93% year-on-year; the export value of health products was US$116.694 million, an increase of 33.49% year-on-year; the exports of Chinese patent medicines were 14.61518 million. The United States dollar, an increase of 18.55%.
The EU and China Hong Kong have always been the two pillar markets for Chinese medicine exports. Although Chinese patent medicines account for a relatively small proportion in the export structure of Chinese medicines, the registration of Chinese patent medicines in the EU is a crucial step in the internationalization of Chinese medicine and cannot be ignored.
The reporter learned that at present, some companies are actively working hard to secure the successful registration of products in the EU before the end of the transitional period. It is reported that Chengdu Dioxinxuekang Capsule in Chengdu, Sichuan Province has passed the review of the Dutch drug administration department. The Dioxinxuekang capsule production line has also passed the EU GMP certification and is expected to become the first therapeutic Chinese proprietary drug product to enter the international market; Guangyao Group Qixing Pharmaceutical Acquired the project of simple registration of traditional British herbal products and GMP certification of EU (UK) Drugs; Lanzhou Foci "Lanshan" brand concentrated Angelica Pill has also been approved and formally accepted by Swedish National Drug Administration, and pre-assessment has also been passed. .
In fact, although the European Union has issued the "Regulations on Traditional Plant Drug Registration Procedures", it does not require that all Chinese medicine products will be managed by drugs in the future. “Actually, many Chinese medicine products can also be legally sold in the European Union according to food, food supplements or cosmetics.†Wang Haitao, a manager of a franchised Chinese medicine foreign trade company, told reporters that the EU and Hong Kong have always been the company’s major export markets, compared to Hong Kong’s. The threshold is lower than that of the European Union. At present, there is not yet one product registered in the EU, because companies are generally unable to provide proof of the 15 years of sales in the EU as stipulated in the “Directive of Traditional Plant Drug Registration Proceduresâ€. However, at the same time, he disclosed that at present, the company is actively applying for Chinese-style Chinese herbal medicines, and more than 90 varieties will be declared and completed before the end of this year. They are all new varieties exported to the EU market.
Drug research data needs to be improved
Yu Zhibin, a member of the Chinese Medicinal Insurance Association, told this reporter that the current stable and reliable compound preparations for quality control standards are still registerable in many EU countries. It is reported that Britain, Finland and Germany have already approved the registration of a compound preparation containing 2 to 13 components. Of the traditional Chinese herbal medicines that are registered, at least nine components are also traditional Chinese medicines.
Yu Zhibin introduced that Chinese medicines are registered on the European Union market. Currently, there are mainly two ways of registration and listing. Among them, Chinese medicines that have never been listed in the European Union, or those that have already been marketed in the European Union but are required to apply for new indications, are all eligible for registration.
It is reported that for the registration of traditional Chinese medicines that have never been listed in the European Union, the EU has requested new clinical research data and clinical trial data. The relevant drug administration agencies of the European Union must conduct safety, effectiveness, and quality controllability. Strict review. For the Chinese medicines that require new indications, the EU requires that they must be complete varieties of Chinese medicines. If the applicant can provide scientific literature on safety and efficacy, the EU will not have to re-examine clinical data and clinical trials.
Werner Kanos, the official of the German Federal Drug and Medical Device Authority, stated that “requiring 15 years of use in the EU†has become an obstacle that everyone is concerned about. In fact, it can be provided by the Chinese community, and exceptions can be released. However, he did not give details on the specific release criteria.
It is understood that for registration on the market, the EU allows eligible traditional herbal medicines to simplify filing requirements. At the same time, for the products listed on the market, if there is a list of EU herbal monographs or EU raw materials, the traditional use of evidence and expert reports, literature or new research materials can be exempted. It is reported that the European Union's "Regulations on Traditional Plant Drug Registration Procedures" stipulates that traditional herbal medicines "have at least 30 years of medicinal history before the filing date, including at least 15 years of use history in the EU." Proof of the above-mentioned history of traditional application is based on publicly published literature, expert reports and customs records of import and export records also belong to the certification document.
In addition, the reporter also learned that the Registration Department of the State Food and Drug Administration is currently stepping up its research on the guiding principles of research techniques for natural medicines. The introduction of this policy will provide clinical research data and clinical trials on the future of Chinese medicine exports to effectively meet international demand. The international convergence of other technical indicators is of great benefit.
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